Pressure-controlled intermittent coronary sinus occlusion apparatus and method

• US 4,934,996 A
• Filed: 01/31/1986
• Issued: 06/19/1990
• Est. Priority Date: 02/27/1984
• Status: Expired due to Term

• Current Assignee: Werner Mohl
• Original Assignee: Boston Scientific Corporation
• Inventors: Mohl, Werner, Tolkoff, Marc J.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/824,721
• Time in Patent Office: 1,600 Days
• Field of Search: 128/1 D, 128/662-663, 128/673-674, 604/49, 604/96, 604/99
• US Class Current: 600/17
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/102 driven by a solenoid-activated pump
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 60/143 inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
• CPC Class Codes: A61M 60/268 : the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/274 : the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 : Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/32 : of heart muscle tissues, e.g. using coronary sinus occlusion
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/497 : for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/531 : using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61M 60/833 : Occluders for preventing backflow

Abstract

The coronary sinus is intermittently occluded by use of means for occluding the sinus, a pressure transducer for sensing the fluid pressure within the sinus and providing corresponding fluid pressure signals, and a controller responsive to the transducer and arranged to provide trigger signals to the occluding means to trigger an occlusion and to interrupt the occlusion, the system being characterized in that the controller is arranged to estimate a plateau level of the fluid pressure during each occlusion and for providing a trigger signal to interrupt each occlusion on the basis of the estimate. The duration of the interruption before the next occlusion is controlled in response to the volume flow in the sinus during the interruption. Pharmacological agents are injected into the sinus during the occlusion, for retroprofusion to the heart tissue. An analysis of heart function is obtained by analyzing the local pressure maxima in successive heartbeats during occlusion. Initiation of the next occlusion is time based on fluid pressure signals taken from the sinus during occlusion. The degree of tissue at risk of infraction (or the amount of infarcted tissue) is estimated based on the fluid pressure signals.

Claims

1. Apparatus for intermittently occluding a coronary sinus comprising

means for occluding said sinus,

a pressure transducer for sensing the fluid pressure within said sinus and providing corresponding fluid pressure signals, and

a controller responsive to said transducer having means for providing trigger signals to said occluding means to trigger an occlusion and to interrupt said occlusion, said apparatus being characterized in that

said controller includes means to estimate a plateau level of said fluid pressure during each occlusion and means to provide the trigger signal to interrupt each said occlusion on the basis of said estimate.

2. The apparatus of claim 1 wherein said controller includes means for interrupting each said occlusion before said fluid pressure reaches said plateau level.

3. The apparatus of claim 2 wherein said controller further includes means for interrupting each said occlusion before said fluid pressure reaches a predetermined percentage of said plateau level.

4. The apparatus of claim 1 further characterized by said controller comprising

sensing means for sensing said fluid pressure signals,

first analysis means for determining and storing a local maximum value of said pressure for each heartbeat from said stored sensed signals,

second analysis means for estimating in real time said plateau level from said stored local maxium values, and

comparison means for comparing a predetermined percentage of said estimated plateau level with successive said local maximum values and generating said trigger signals for triggering interruption of each occlusion at a time dependent on the result of said comparison.

5. The apparatus of claim 2 or 4 further characterized by said predetermined percentage being greater than 70% and less than 98%.

6. The apparatus of claim 5 further characterized by said predetermined percentage being about 94%.

7. The apparatus of claim 4 wherein said second analysis circuitry includes means for estimating said plateau level by fitting said stored local maximum values to an exponential curve.

8. The apparatus of claim 1 further characterized in that said occluding means comprises an inflatable element in said sinus, and a pump for selectably inflating said inflatable element in response to said trigger signals.

9. The apparatus of claim 1 further characterized in having means responsive to the volume flow in said sinus for commencing each period of occlusion of said sinus.

10. The apparatus of claim 1 further characterized in having means to display the pressure maxima for the succession of heartbeats that occurs during an occlusion to enable evaluation of the relationship of said maxima for indication of the state of health of the heart tissue.

11. The apparatus of claim 1 further characterized in having means during said occlusion to infuse a pharmacological agent into said sinus, whereby said agent can be retroperfused to heart tissue.

12. A method for intermittently occluding a coronary sinus, comprising

providing means for occluding said sinus and for measuring the local pressure maximum within said sinus during each heartbeat,

causing occlusion of said sinus,

measuring the local pressure maxima for successive heartbeats during said occlusion, said method being characterized by the steps of

estimating the plateau level of said local pressure maxima, and

interrupting said occlusion on the basis of said estimate.

13. The method of claim 12 further comprising interrupting said occlusion before fluid pressure reaches said plateau level.

14. The method of claim 12 further comprising interrupting said occlusion when a said local pressure maximum reaches at least a predetermined percentage of said plateau level.

15. The method of claim 14 further characterized in that said predetermined percentage is at least 70% and less than 98%.

16. The method of claim 15 further characterized in that said predetermined percentage is about 94%.

17. The method of claim 12 further comprising sensing the volume flow following cessation of the preceeding occlusion period and commencing the next period of occlusion of said sinus in response to the volume flow following cessation of the preceding occlusion period.

18. Apparatus for intermittently occluding a coronary sinus comprising

means for occluding said sinus, and

a controller having means for providing trigger signals to said occluding means to trigger an occlusion and to interrupt said occlusion,

said apparatus being characterized in that

a sensor is provided for delivering flow signals indicative of the volume flow of fluid in said sinus during periods when said occlusion is being interrupted, and

said controller includes means to trigger the initiation of the next said occlusion at a time determined by said flow signals.

19. The apparatus of claim 18 characterized in that said flow signals represent the velocity of flow of fluid in said sinus.

20. The apparatus of claim 18 wherein said sensor comprises means for determining said flow signals based on the fluid pressure in said sinus as a function of time.

21. The apparatus of claim 18 further characterized in that said controller includes

sampling means for sampling said flow signals and storing said samples,

analysis means for determining from said stored samples the time when the peak of said volumen flow occurs during each period of interruption of said occlusion, and

trigger means for delivering a trigger signal to trigger the next said occlusion at a time determined by when said peak occurs.

22. The apparatus of claim 21 further comprising means for triggering said next occlusion after said peak occurs.

23. The apparatus of claim 18 further characterized in that said occluding means comprises an inflatable element in said sinus and a pump for selectably inflating said inflatable element in response to said trigger circuitry.

24. A method for intermittently occluding a coronary sinus comprising

providing means for occluding said sinus,

occluding said sinus, and

thereafter interrupting said occlusion, the method being characterized by the steps of

determining the flow within said sinus during said interruption,

determining the time of the peak of said flow, and

triggering the next occlusion of said sinus at a time determined by when said peak occurs.

25. Apparatus for intermittently occluding a coronary sinus comprising

means for occluding said sinus, and

a controller having means for providing trigger signals to said occluding means to trigger an occlusion and to interrupt said occlusion,

said apparatus being characterized in that

a pressure transducer is provided for sensing the fluid pressure within said sinus during said occlusion and providing corresponding fluid pressure signals, and

said controller has means for triggering the initiation of the next said occlusion at a time based on said fluid pressure signals.

26. The apparatus of claim 25 wherein said controller further comprises means for triggering said initiation on the basis of successive pressure maxima of said fluid pressure signals.

27. The apparatus of claim 25 wherein said controller further comprises means for triggering said initiation on the basis of successive pressure minima of said fluid pressure signals.

28. The apparatus of claim 25 wherein said controller further comprises means for triggering said initiation on the basis of a combination of parameters derived from successive pressure maxima and minima of said fluid pressure signals.

29. The apparatus of claim 28 wherein said controller further comprises means for triggering said initiation on the basis of fitting said pressure maxima and said pressure minima to exponential curves.

30. The apparatus of claim 29 wherein said means for triggering includes means that trigger said initiation on the basis of a combination of parameters including the asymptotic plateaus of said exponential curves.

31. The apparatus of claim 29 wherein said means for triggering includes means that trigger said initiation on the basis of a combination of parameters including the time constants of said exponential curves.

32. The apparatus of claim 28 wherein said means for triggering includes means that trigger said initiation on the basis of a combination of parameters including heart rate.

33. A method for intermittently occluding a coronary sinus comprising

providing means for occluding said sinus,

occluding said sinus, and

thereafter interrupting said occlusion,

the method being characterized by the steps of:

sensing the fluid pressure within said sinus during said occlusion and providing corresponding fluid pressure signals, and

triggering the initiation of the next said occlusion at a time dependent on said fluid pressure signals.

34. The method of claim 33 further comprising causing said triggering to be dependent on successive pressure maxima and successive pressure minima of said fluid pressure signals.

35. The method of claim 34 further comprising causing said triggering to be dependent on a combination of parameters derived from said successive pressure maxima and minima.

36. The method of claim 35 further comprising causing said triggering to be dependent on fitting said pressure maxima and said pressure minima to exponential curves.

37. The method of claim 35 wherein said causing said triggering includes causing said triggering to be dependent on a combination of parameters including heart rate.

38. The method of claim 35 wherein said causing said triggering includes causing said triggering to be dependent on a combination of parameters including the asymptotic plateaus of said exponential curves.

39. The method of claim 35 wherein said causing said triggering includes causing said triggering to be dependent on a combination of parameters including the time constants of said exponential curves.